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Topamax Lawsuits

FDA Warns of Oral Birth Defect Risks for Babies of Mothers Taking Topamax

On March 4, 2011, the Food and Drug Administration (FDA) provided data suggesting that the medication Topamax (topiramate) and its generic versions increase the chances that a baby will suffer the birth defects cleft lip and cleft palate when a mother takes Topamax during pregnancy. Topamax is prescribed to treat certain kinds of seizures for individuals who have epilepsy. It is also used to prevent migraine headaches.

With this potential risk of Topamax birth defects in mind, however, a woman should not suddenly stop taking Topamax, even if she is pregnant. Immediately going off of Topamax before speaking with your health care professional can cause serious health problems. Not treating epilepsy during pregnancy can be unsafe to women and their developing babies. It is important for a woman to discuss alternative antiepileptic drugs with her physician if she believes she is pregnant or thinks she will become pregnant.

It is the responsibility of health care professionals to caution patients of childbearing age about the possible risks to a fetus if a woman becomes pregnant while taking Topamax.

Topamax Oral Clefts

Topamax birth defects include oral clefts; more specifically, cleft lip and cleft palate. These oral birth defects affect the lip or palate, causing them to not fully fuse together during the first trimester of pregnancy. The potential side effects of Topamax are very risky, since the first trimester is often a time when many women do not know they are pregnant. Oral cleft defects range from a small indentation in the lip to a groove that runs into the top of the mouth and nose. Cleft lips and cleft palates can cause a child to have difficulty eating and talking, in addition to problems with ear infections.

The North American Antiepileptic Drug (AED) Pregnancy Registry has provided data suggesting a heightened frequency of oral clefts in infants exposed to Topamax during the first trimester of pregnancy. Similar data from the United Kingdom Epilepsy and Pregnancy Register supports this argument. It was found that infant single therapy exposure to Topamax during pregnancy lead to a 1.4 percent occurrence of oral clefts in comparison to an occurrence of 0.38 - 0.55 percent in infants exposed to different antiepileptic medications. Babies born to mothers who did not have epilepsy and were not taking other antiepileptic pharmaceuticals experienced an occurrence of 0.07 percent.

Topamax oral birth defects are serious, imposing not only physical challenges for a baby, but also causing potentially causing emotional distress coping with a deformity, surgery, and recovery. Parents also encounter financial and emotional challenges when their child has suffered a birth defect due to a drug.

Although Topamax will now have a stronger warning label and pregnancy Category D suggesting that the possible benefits in pregnant women may outweigh the risks in certain situations, there is still human fetal risk and many infants have already suffered. The FDA notes that from January 2007 through December 2010, about 32.3 million topiramate prescriptions were given and about 4.3 million patients filled topiramate prescriptions from U.S. outpatient retail pharmacies.

Topamax Lawyer

Do you need a Topamax birth injury lawyer? While hiring an attorney might be the last thing on your mind after your child has suffered an oral birth defect, time plays a critical role in whether you can obtain compensation for pain and suffering, medical expenses, and other damages. At Anapol Schwartz, our Topamax attorneys know that you have a lot on your mind. It's our job to ensure that your rights are protected and that the proper evidence is gathered to ensure a successful case outcome. Contact us today for more information.